藍帆醫療(002382.SZ):子公司產品獲得中國NMPA、美國FDA、日本PMDA註冊
格隆匯4月19日丨藍帆醫療(002382.SZ)公佈,近日,公司下屬境內子公司收到國家藥品監督管理局(簡稱“NMPA”)的通知,子公司的心闊®冠脈藥物洗脱支架獲得了中國NMPA的註冊證;同時,美國子公司針對高出血風險病人的BioFreedom™心臟支架獲得美國食品藥品監督管理局(簡稱“FDA”)的註冊;日本子公司的BioFreedom™ Ultra心臟支架獲得日本醫藥品醫療器械綜合機構(簡稱“PMDA”)的註冊。
心闊®冠脈藥物洗脱支架其在國內的獲批將進一步豐富公司的產品組合,滿足多元化的市場需求,有效提升公司的核心競爭能力,是公司應對行業政策變化的重要支撐。
BioFreedom™獲得FDA註冊和BioFreedom™ Ultra獲得日本PMDA註冊是公司冠脈業務發展的重要里程碑,將為臨牀醫生和患者提供新的治療選擇,有利於進一步提升公司的品牌效應,擴充公司海外銷售產品品類並加快公司開拓國際市場的步伐。
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